Trial Outcomes & Findings for Self-Propelled Percutaneous Endoscopic GastroJejunostomy (PEG-J) (NCT NCT01551095)

Results Overview

One week after the procedure patients were called by one of the study investigators and were asked whether or not they had Abdominal pain, Nausea or Vomiting after the procedure.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

From date of PEGJ placement up to 3 weeks

Results posted on

2017-03-31

Participant Flow

Patients were enrolled between January 2012 and May 2012 in a tertiary academic center

Participant milestones

Participant milestones
Measure	PEGJ Patients in this arm will receive self-propelled balloon PEGJ tube. PEGJ tube: The self-propelled PEGJ feeding tube
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Self-Propelled Percutaneous Endoscopic GastroJejunostomy (PEG-J)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PEGJ n=7 Participants Patients in this arm will receive self-propelled balloon PEGJ tube. PEGJ tube: The self-propelled PEGJ feeding tube
Age, Customized	38.3 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of PEGJ placement up to 3 weeks

One week after the procedure patients were called by one of the study investigators and were asked whether or not they had Abdominal pain, Nausea or Vomiting after the procedure.

Outcome measures

Outcome measures
Measure	PEGJ n=7 Participants Patients in this arm will receive self-propelled balloon PEGJ tube. PEGJ tube: The self-propelled PEGJ feeding tube
Safety: Number of Participants With Adverse Events Abdominal Pain	1 participants
Safety: Number of Participants With Adverse Events Nausea	0 participants
Safety: Number of Participants With Adverse Events Vomiting	0 participants

SECONDARY outcome

Timeframe: From date of PEGJ placement up to 3 weeks

An Abdominal X-ray was obtained 3 weeks after the procedure to check whether or not there was any PEGJ feeding tube migration.

Outcome measures

Outcome measures
Measure	PEGJ n=7 Participants Patients in this arm will receive self-propelled balloon PEGJ tube. PEGJ tube: The self-propelled PEGJ feeding tube
Number of Participants With Retrograde Migration of PEGJ Feeding Tube Within 3 Weeks of Placement	0 participants

Adverse Events

PEGJ

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PEGJ n=7 participants at risk Patients in this arm will receive self-propelled balloon PEGJ tube. PEGJ tube: The self-propelled PEGJ feeding tube
Gastrointestinal disorders Abdominal pain	14.3% 1/7 • Number of events 1

Additional Information

Mouen Khashab

Johns Hopkins University

Phone: 443-287-1960

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place